Search Results

The Solo™ / Swing Maxi™ breast pumps are powered breast pumps to be used by lactating women to express and collect milk from their breasts.

The Solo™ / Swing Maxi™ breast pumps are intended for a single user.

The breast pumps are intended to be used in a home environment.

Solo™ and Swing Maxi™ are breast pump systems intended to be used in a home environment (or similar such as an office). Solo™ and Swing Maxi™ comprise a pump unit, power adapter, and one (Solo™) or two (Swing Maxi™) PersonalFit Flex™ connectors that include the connector body, membrane (diaphragm), and connector back cap. The breast pump systems also include breast shields (21, 24, 27, and 30 mm), bottle lid, bottle stand, and tubing. The device is provided non-sterile.

The breast pumps can be used on one breast (single pumping; Solo™ and Swing Maxi™)) or on both breasts (double pumping) at the same time (Swing Maxi 101).

The Solo"M and Swing Maxi™ breast pumps feature 2-Phase Expression® technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm. A DC motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk. The pump unit includes the following features:

• user-adjustable controls: "On/Pause/Off" for powering on/off or pausing the device, "Letdown" for switching between pumping modes, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
• a port for connection of the tubing that channels the vacuum for breast pumping;
• a port for connection of the power supply;
• a central LED light as status indicator; and
• a textile lanyard as an interface to the user's clothes/body.

The Solo™ and Swing Maxi™ breast pump systems allow the user to adjust the vacuum levels in both phases (stimulation and expression). The powered breast pumps are preprogrammed with variable vacuum levels and cvcle rates. The powered breast pumps are capable of providing vacuum levels from -45 to -140 mmHg with cycle speeds up to 111 cycles per minute for stimulation and from -45 to -245 mmHg with cycle speeds from 75 to 45 cycles per minute for expression.

Two different product configurations are available for the Swing Maxi™ breast pump: without and with Bluetooth®. These two product configurations share the same mechanical and electrical design components; however, the Swing Maxi111 breast pump with Bluetooth® additionally features always-on enabled Bluetooth® connectivity. This allows monodirectional wireless data transmission from the breast pump to a Bluetooth®-enabled personal mobile device, such as a smartphone or tablet computer. When the Medela FamilyTM smart application is installed on a compatible mobile device and the device is paired via Bluetooth® with the breast pump unit, the user can: automatically record pumping data (session length, phases, and vacuum intensity levels), manually input the amount of milk expressed, and get notified when the battery is low as indicated in provided instructional material and in-app information.

The provided document is a 510(k) premarket notification for the Medela Solo™ / Swing Maxi™ breast pumps. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document states that the breast pumps comply with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, and usability. It also lists performance data provided to support the substantial equivalence determination. These performance data are:

• Electrical Safety testing: In accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, and IEC 60601-11:2015.
• Risk analysis: In accordance with ISO 14971:2007.
• Electromagnetic compatibility testing: In accordance with IEC 60601-1-2:2014.
• Biocompatibility evaluation: Completed according to FDA guidance "Use of International Standard ISO 10993-1," concluding no new testing was required as patient-contacting materials are identical to the predicate device.
• Software validation: In accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The software was considered a "Moderate" level of concern.
• Bench testing: Conducted to determine minimum and maximum vacuum levels and cycle rates compared to specifications.
• Battery and pump use life testing: Conducted to demonstrate device maintenance of specifications throughout its use life.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria are met for an AI/ML device because the provided text is for a traditional medical device (breast pump) and does not describe an AI/ML component or associated performance studies against specific AI/ML metrics.

If you have a document related to an AI/ML medical device, please provide that, and I will do my best to extract the information you need.

Ask a specific question about this device

The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.

The Freestyle Flex™ breast pump is intended for a single user.

The breast pump is intended to be used in a home environment.

The Medela Freestyle Flex™ breast pump system is comprised of the Freestyle Flex™ pump (motor unit), the PersonalFit Flex connector (including membranes and connector bodies), PersonalFit Flex breast shields (21, 24, 27, 30 mm), tubing, bottles, carry bag, cooler with cooling element, and Power Adapter.

The Medela Freestyle Flex™ breast pump system is used to express and collect milk from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. Pumping with the Freestyle Flex 110 breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).

The Freestyle Flex™ breast pump allows the user to adjust the vacuum levels. Two suction patterns are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -45 to -245 mmHg with cycle rates up to 111 cycles per minute. The device is AC/DC powered and incorporates a DC motor with membrane aggregate in its pump motor unit. The device is provided non-sterile.

The Freestyle Flex ™ breast pump provides the following user features:

• . Five buttons for user adjustment of on/off, let-down, increase vacuum, decrease vacuum, start/pause.
• 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ●
  • o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing.
• o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
• "Let-down" control to change between stimulation phase and expression phase. .
• Option of either single or double breast pumping. .

This document is a 510(k) Summary for the Medela Freestyle Flex™ breast pump and focuses on demonstrating substantial equivalence to a predicate device (Medela Freestyle® Breast Pump K150499) rather than presenting a study to prove performance against specific acceptance criteria in the traditional sense of clinical performance measures (e.g., sensitivity, specificity, accuracy for diagnostic devices).

Therefore, some of the requested information regarding acceptance criteria and study design (especially related to expert ground truth, adjudication, MRMC, and standalone performance metrics) is not applicable or cannot be directly extracted from this type of regulatory submission for a powered breast pump. This submission is primarily concerned with safety and effectiveness through technological comparison and conformance to standards.

However, I can extract information related to the technical specifications and non-clinical testing performed to support the substantial equivalence claim.

Here's the closest representation of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a breast pump, "acceptance criteria" primarily revolve around meeting technical specifications for functionality, safety standards, and equivalence to a predicate device. The "reported device performance" refers to the device adhering to these specifications during testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not specify a "test set" in the context of clinical data. The performance claims are based on non-clinical bench testing. Therefore, sample sizes for human subjects or data provenance (country/retrospective/prospective) are not applicable or provided here. The tests are laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth from experts is not a concept used in this type of non-clinical bench testing for a breast pump. Performance is measured against predefined engineering specifications and international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no clinical test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant for a breast pump's regulatory submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device requiring standalone performance evaluation in the context of diagnostic accuracy. The "standalone" performance here refers to bench testing of the pump's physical and electrical specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests are the engineering specifications and established international safety and performance standards for powered breast pumps and electrical medical equipment. For example, a vacuum level output of -245 mmHg is measured directly against a known standard.

8. The sample size for the training set

Not applicable. This device does not use machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Ask a specific question about this device